Many Drugs Prescribed for Elderly Americans Are Risky

From Duke University - Many Americans over the age of 65 hold prescriptions for drugs considered potentially risky for elderly patients, according to a new study by Duke University Medical Center researchers. The finding emphasizes a need for greater awareness among physicians about the risks presented by commonly prescribed medications as people age and for additional measures to monitor prescription drug use, the team said.

The Duke researchers found that over the course of a year one in five elderly Americans whose benefits were processed by one of the largest pharmaceutical benefits managers in the U.S. filled a prescription for at least one drug classified as a "drug of concern," according to established criteria known as the Beers list. Of those claims, half were for drugs -- including the anti-depressant amitriptyline (Elavil®, Endep®, Vanatrip®) and anti-anxiety drug diazepam (Valium®) -- with potential for severe adverse effects in older people, the researchers reported in the Aug. 9, 2004, issue of Archives of Internal Medicine.

"Although criteria for drugs to avoid in the elderly have been around for a long time, the amount of potentially inappropriate prescribing for older patients remains really high," said Lesley Curtis, Ph.D., a member of the Duke Center for Clinical and Genetic Economics and lead author of the study. The center is part of the Duke Clinical Research Institute. The work was supported by a Centers for Education and Research on Therapeutics cooperative agreement between the Agency for Healthcare Research and Quality in Rockville, Md., and the University of Arizona Health Sciences Center in Tucson.

People over the age of 65 make up less than 15 percent of the U.S. population, yet they account for nearly one-third of drug consumption, noted Kevin Schulman, M.D., director of the Duke Center for Clinical and Genetic Economics and senior author of the study. Elderly individuals more often have multiple chronic conditions, increasing the likelihood that they take several drugs concurrently, he added. Furthermore, many drugs present increasing risk for people as they age due to changes in metabolism and excretion, whose effects are complicated by the number of prescription drugs taken.

The list of criteria for determining the appropriate use of medication in elderly living in nursing homes was developed in 1991 by a team led by Mark Beers at the University of California, Los Angeles, culled from the opinions of a panel of experts. In 1997, Beers updated the original list, initially intended primarily for institutional use, for use in any setting. The list named 28 medications or classes of medications considered inappropriate for use in elderly patients. The panel deemed 14 of those 28 medications to have potentially severe adverse outcomes when taken by older people.

In the current study, the Duke team analyzed the prescriptions filled for all patients over 65 who filed claims in 1999 through the outpatient prescription claims database of AdvancePCS (now part of Caremark Rx, Inc.). The study population included representatives of all 50 states, the District of Columbia, Puerto Rico and two U.S. territories.

Of the 765,423 people included in the study, more than 20 percent (162,370) filled a prescription for one or more drugs of concern during the year, they reported. While most patients who made such a claim filled a prescription for a single Beers list drug, nearly 16 percent (25,550) made claims for two risky drugs and 4 percent (6,402) filled prescriptions for three or more Beers list drugs within the same year.

In the study, 41 percent of elderly beneficiaries who filled a prescription for a drug on the Beers list did so for a psychotropic drug. Claims for the anti-depressants amitriptyline and doxepin (Adapin®, Sinequan®, Zonalon®) alone accounted for nearly one quarter of the total claims for drugs considered potentially risky for elderly patients, the team reported. Neuromuscular agents ranked second among the most commonly prescribed classes of Beers list drugs.

The results mirror those of an earlier study of prescriptions to the elderly in 1987, which found that 23.5 percent of elderly patients filled prescriptions for one or more of the Beers list drugs, Curtis added. "Despite earlier warnings, we're not getting any better in the use of these drugs," she said.

The findings suggest that some doctors may be uninformed about the increasing risks presented by common medications as people age, Curtis said. Others might be familiar with the list, but believe that the benefits outweigh the risks in some situations, she added.

The team notes that pharmaceutical claims databases could offer a useful tool to help reduce the problem by screening prescriptions and issuing patient-specific alerts when physicians prescribe inappropriate drugs or drug combinations, she said. Physicians' compliance with the guidelines might also be improved by bolstering the clinical evidence for the risks presented by particular drugs when taken by older patients, she added, noting that the elderly are rarely included in the clinical trials that generate information about drugs' side effects.

Archives of Internal Medicine published a more recent update of the Beers list including 48 medications or classes of medications to avoid in adults age 65 or older in their Dec. 8, 2003, issue.

Collaborators on the study include Truls Ostbye, M.D., and Veronica Sendersky, of Duke; Steve Hutchison, Ph.D., Peter Dans, M.D., and Alan Wright, M.D., of AdvancePCS; and Raymond Woosley, M.D., of University of Arizona Health Sciences Center.

FULL STUDY: Medication Use Leading to Emergency Department Visits for Adverse Drug Events in Older Adults

Evidence Keeps Mounting: Study says regular mobile use increases tumour risk

Regular use of mobile telephones increases the risk of developing tumours, a new scientific study by Israeli researchers and published in the American Journal of Epidemiology revealed on Friday.

An extract of the report seen by Israel's Yedoit Aharonot newspaper put the risk of developing a parotid gland tumour nearly 50 percent higher for frequent mobile phone users -- more than 22 hours a month.

The risk was still higher if users clamped the phone to the same ear, did not use hands-free devices or were in rural areas.

"Analysis restricted to regular users or to conditions that may yield higher levels of exposure (eg heavy use in rural areas) showed consistently elevated risks," said an abstract of the report in the US journal made available to AFP.

The study included 402 benign and 58 malignant incident cases of parotid gland tumour diagnosed in Israel at age 18 years or more, in 2001-2003.

The research was led by Dr Siegal Sadetzki, a cancer and radiation expert at the Chaim Sheba Medical Centre in Israel and as part of a World Health Organisation project.

Copyright © 2007 Agence France Presse.

And from The Indian Express -
By IE
Tuesday November 27, 01:28 AM
Continuous use of cell phones can pose a serious threat to your reproductive health, says a study conducted by the Indian Council of Medical Research (ICMR). The Preliminary results of the study have indicated significant reduction in the testicular size, weight and sperm count due to the Radio Frequency Radiation (RFR) emitted from cell phones.
Experts at the division of reproductive health, mobile and nutrition of ICMR are working on a long-term study on a larger sample size to find out the effects of the RFR. Experts say the results of the preliminary study showing the adverse effects, "may be possible if not probable". "Even as the literature does not establish evidence about the safety or risk of the RFR, but the growing scientific evidence have of late indicated towards the bio and adverse effects of the RFR," said an expert with ICMR.

Further work is on by the council to get a broader view on it. It has developed a protocol to study "effects of radio frequency radiation emitted from cell phone and cell masts on male reproduction." A task force, consisting of various scientists has also been developed and has been working on the "hazards of environment pollution and changing lifestyle on reproduction".

To start with, the research council has short listed the National Capital to conduct the study and then proposes to reach other metropolitans. "The study is proposed to be carried out as a pilot study in Delhi at different sites for two years duration. Based on the results from this study, there is a possibility to extend it to other metros," added the expert. A survey done by the retired technical experts of the Defence Research and Development Organisation (DRDO) earlier had shown radiation power levels much above the permissible levels.

According to the International Commission of Non Iodised Radiation protection (WHO and EU) radiation power level should be 600 microwatt/cm2. In most areas of Delhi, the levels are found to be as higher as 7620 microwatt/m2.

Work in the same direction has earlier been also done by experts like Prof J Behari of School of Environmental Sciences, JNU. His department had found out that chronic exposure to microwave and mobile radiations causing increase in double strand DNA break in sperm and brain cells of the rats. Experts recommend against keeping mobile phone in one's trouser or shirt pocket.

The doctors say that this is a new observation, which needs to be looked into with a broader prospect. "Uninterrupted usage of mobile phones and problems like brain tumour, heart attack and even cancer have been linked with. But the thing that needs to be looked into are the other compounding factors to establish the cause and effect relationship between the two," said Dr NP Singh, professor of medicine, Maulana Azad Medical College, New Delhi.

Thank you for the comment on CT scans

We thank Dr. Eldridge for taking the time to post a comment here on our blog.

Lynne Eldridge MD
Author, "Avoiding Cancer One Day At A Time"
www.avoidcancernow.com

Items your pet should never come in contact with - Holiday Alert

keep your eyes open!

Low Toxicity - Balsam/pine/cedar/fir; poinsettia leaves/stems; angel hair (spun glass); Christmas tree preservatives; snow sprays/snow flock.

Moderate Toxicity - Moderate to high toxicity holly berries and leaves.

Highly Toxicity - Mistletoe (especially berries); epoxy adhesives; and antifreeze. Please note that some items have special problems. For example, angel hair is usually considered to be of low toxicity but it can irritate eyes, skin, and the gastrointestinal tract in small and large pets alike. Snow flock can cause problems if sprayed into the mouth or inhaled. Antifreeze deserves special mention because even a very small amount can be rapidly fatal to pets

Christmas tree ornaments and small toys can also cause obstructions in the gastrointestinal tract if swallowed and chocolate of any type, should never be given to a pet at any time.

According to the American Veterinary Association thousands of household pets are injured each year around the holidays from Plants and Decorations. See your local veterinarian if your cat or dog comes in contact or digest any of the items listed. We hope this year with extra care and a watchful eye, you and your pets will have a safe and happy holiday season.

FDA's inability to keep up with scientific advances means that American lives are at risk

Big Pharma has had its hand in and on the FDA and Congress for decades now and they just garnered another blow to safety with the pasage of S1082 in the past months.

Now with even more money things, as we expected, show no sign of improvement.

Certainly there is no effort to encourage your control of your own health and no effort to support your right of access to health care of your choice and access to supplemnts in therapeutic amounts.

FDA science dearth puts public health at risk

By Kim Dixon

WASHINGTON, Dec 3 (Reuters) - Lives are at risk because the U.S. Food and Drug Administration is woefully behind in the latest scientific advances and is under funded, a panel of advisers to the agency said at a public meeting on Monday.

Inadequate staffing, poor retention, out-of-date technology and a lack of resources mar the FDA's ability, the report by a subcommittee of the agency's Science Board said.

(A copy of the 60-page report, FDA Science and Mission at Risk, can be found at www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html.)

"FDA's inability to keep up with scientific advances means that American lives are at risk," the report said.

The panel, chaired by Gail Cassell, vice president for scientific affairs at Eli Lilly & Co. (LLY.N: Quote, Profile, Research), and representatives from Genentech Inc (DNA.N: Quote, Profile, Research) and Wyeth (WYE.N: Quote, Profile, Research), among others presented their findings to FDA Commissioner Andrew Von Eschenbach and other agency officials.

Eschenbach asked the Science Board to examine the problems that have plagued the agency in recent years including recalls of drugs, contaminated food and toxic toothpaste. The agency regulates products from drugs to food and cosmetics representing about $1 trillion, or a quarter of every dollar spent in the United States, according to the report.

The U.S. Congress passed more than 100 laws expanding the FDA's authority since 1988, but has not increased the funding appropriately, the report found.

Among its recommendations, the panel suggested hiring more scientific talent, naming a chief scientific officer and reorganizing how the agency handles science issues.

The FDA is requesting $2.1 billion in its fiscal year 2008 budget, a 5.3 percent increase over the current budget.

"Without a significant increase in resources," the "recommendations will be superfluous," the report warned.

The panel's report said the agency's track record in regulating the safety of the food supply - noting a systems failure during a recent E. coli food contamination inquiry - " has drawn attention and resources away from FDA's ability to develop the science base and infrastructure needed to efficiently support innovation in the food industry."

Public health is at risk as "reports of product dangers are not rapidly compared and analyzed, inspectors' reports are still hand written," the report said.

Poor retention of critical staff was faulted. The report noted the turnover rate of the science staff is twice that of other government agencies.

The agency lacks a good system of talking to scientists outside the agency, "thus limiting infusion of new knowledge and missing opportunities to leverage resources," it said.

The panel "was extremely disturbed" at the state of the agency's information technology infrastructure, calling it the "weakest but most critical link."

(Reporting by Kim Dixon; Editing by Leslie Gevirtz)

((kim.dixon@reuters.com; +1 202 354 5848; Reuters Messaging: kim.dixon.reuters.com@reuters.net))

(C) Reuters 2007. All rights reserved.

FDA oblivious to Gardasil's rash of serious side effects

Not ONE but TWO recent reports on the harm being caused by Gardasil vaccination. No, this is not the voice of anti-vaccine folks, it is the voice of the harm coming from an ill tested and limited benefit drug.

The arrogant comments of the doctors are unconscionable.

ALMOST 500 girls have had adverse reactions such as seizures, rashes and paralysis after taking cervical cancer vaccine Gardasil in Australia since it was released in April.

Of those, almost 200 Victorian schoolgirls were affected and 10 girls were admitted to hospital after fainting or collapsing following the jabs.

But leading experts defended the benefits of Gardasil and dismissed controversial reports of overseas deaths as unrelated and fictitious.

Doctors yesterday played down many side-effects as being unrelated, and said figures were low and what was expected in proportion to the number of doses dished out.

More than 13 million doses have been given worldwide.

Some 2.2 million Australian women have received the jab, with almost 500,000 in Victoria.

Gardasil guards against strains of the human papilloma virus that cause 70 per cent of cervical cancers, and is administered to girls under 18 through a national vaccination program.

As of November 30, there had been 496 adverse reaction reports to the Therapeutic Goods Association with the HPV vaccine as the sole suspected cause.

In the US more than 2220 reports were lodged in 12 months, including controversial reports of more than seven deaths.

But Gardasil co-creator Ian Frazer, the Health Department and manufacturer CSL yesterday dismissed allegations of associated deaths in the US, claiming the women died of unrelated causes.

Prof Frazer, a leading immunologist and former Australian of the Year, blamed anti-immunisation groups for exaggerating data as a scare tactic against inoculation.

Immunisation specialist Dr Jim Buttery, who works at the Royal Children's Hospital, declared Gardasil safe but said all reports were taken seriously.

Although the TGA refused to reveal detailed results, it said Gardasil was monitored by the US FDA and Centres for Disease Control, and in Australia by the Adverse Drug Reaction Advisory Committee, the Australian Technical Advisory Group on Immunisation and the National Immunisation Committee.

The TGA's Dr Rohan Hammett said: "All . . . advised that current rates of adverse reactions are consistent with those expected with any vaccine."

FDA: 28 Miscarriages No Reason to Reexamine Gardasil
By Fred Lucas
CNSNews.com Staff Writer
December 06, 2007

(CNSNews.com) - Since June 2006, when the HPV vaccine Gardasil was approved by the Food and Drug Administration, there have been 28 reported cases in which pregnant women miscarried after receiving the vaccine.

Nonetheless, based on the clinical trials done prior to approval of the drug - which indicated that miscarriages among pregnant women given Gardasil were statistically consistent with miscarriages among women given placebos and in the general population - the FDA remains convinced the vaccine is safe and is not further investigating its effect on pregnant women.

In May, a 24-year-old woman suffered a miscarriage, which an investigator in a report issued to the federal government said, "may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy."

In July, a 17-year-old girl from Texas was unaware she was pregnant when she got her second dose of Gardasil. She miscarried, but the cause of the miscarriage hasn't been determined, according to a report.

The reasons for two other miscarriages this year in Florida - one by a 16-year-old and another by a 24-year-old both - are undetermined, according to reports. But it is known that both women had Gardasil vaccinations shortly before the miscarriages.

Gardasil is the vaccine to prevent the Human Papillomavirus (HPV), a sexually transmitted disease and the leading cause of cervical cancer in women. The package insert for Gardasil states there is "no evidence" the vaccine will cause "impaired female fertility or harm the fetus."

Most of the 28 reports of miscarriage, which were drawn from the Vaccine Adverse Event Reporting System (VAERS), were attributed to "other medical event." VAERS reports contain raw, unanalyzed data sent by concerned parties to the FDA and the U.S. Centers for Disease Control and Prevention.

The only Gardasil side effect the FDA has expressed concern about is dizziness immediately after the shot, FDA spokeswoman Karen Riley said. "We've not seen signals" of a disproportionate problem with Gardasil and pregnant women, she said.

"If you're pregnant, then it means you've been sexually active," Riley said. "So it would be somewhat dubious to get a vaccine you're supposed to have before you're sexually active."

While there is no conclusive evidence that any health problems have been caused by the vaccine, Judicial Watch, the conservative government watchdog group that obtained the VAERS reports through a lawsuit, is concerned that the FDA is not scrutinizing the vaccine more closely.

Judicial Watch President Tom Fitton said his group wants to know more about the FDA's approval of Gardasil and monitoring of potential problems with the vaccine, which some states either have or are considering mandating for school girls.

"Merck lobbied for these mandates," Fitton told Cybercast News Service . "There are moral issues here. But the primary issue is public health and safety. It's interesting why our government downplays the apparent adverse reactions of Gardasil. Why are drugs with a distinct social agenda getting less scrutiny in the approval process?"

Riley stressed that the numbers concerning the pregnancies must be placed in context.

"Have they (Judicial Watch) compared that to a similar group of young pregnant women of the same age group who haven't had Gardasil?" Riley said. "There is always a certain percentage of children born with abnormalities among any sampling. The only way to say if there is a causality relationship is to compare one group to see if they have a higher rate than another group."

A total of 3,461 adverse reactions, including eight deaths, were reported to the government through the VAERS system since the FDA approved the drug.

Reproduction studies were conducted on female rats at doses up to 300 times the human dose, according to Merck. The tests on the lab rats showed no adverse effect on reproduction or pregnancy. However, the company literature on Gardasil said, "It is not known whether Gardasil should be given to pregnant women."

During Merck's clinical trials of 2,226 women, half got the Gardasil vaccine, and the other half got a placebo or empty vaccine. In that group, 40 on Gardasil and 41 on the placebo had an adverse event in their pregnancy.

The most common adverse events were conditions that can result in cesarean section or premature labor. The portions between the Gardasil and placebo were comparable, Merck said.

Merck spokeswoman Jennifer Allen said 2 to 3 percent of the women who became pregnant during the clinical trials had children with problems, and roughly 15 percent of those had miscarriages. This, she said, mirrors the general public of pregnant women, regardless of whether they had the vaccine.

Pointing to the fact that VAERS reports are raw data, she said there was little reason to believe a causal relationship existed.

"It's what you see in the database of the general population," Allen told Cybercast News Service . "VAERS are passive reports. It's plausible someone would get the vaccine, leave the doctor's office and walk into a pole. You could report that and VAERS would accept it."

Much of the controversy surrounding Gardasil pertains to the fact that three states - Massachusetts, New Jersey, and Virginia - are mandating sixth-grade girls get the vaccine, and other states are considering such a mandate.

The three states included an opt-out provision, which would let parents choose not to have the vaccine administered to their child for religious or other reasons.

Meanwhile, 38 other states this year passed or considered some type of legislation either mandating, funding, or educating the public about the vaccine, according to the National Council of State Legislatures. New Hampshire and Alaska adopted a voluntary program that supplies the vaccine for free to girls between ages 11 and 18 who want it.

Meanwhile, abroad, the British Department of Health approved a national mandate for school girls to get the vaccine.

After the FDA approved Gardasil, the Advisory Committee on Immunization Practices recommended routine vaccinations for girls ages 11 and 12. HPV infects 20 million people in the United States, with about 6.2 million new cases each year, according to the Centers for Disease Control and Prevention. HPV is responsible for nearly 70 percent of cervical cancer cases.

The American College of Pediatrics and the New England Journal of Medicine have voiced opposition to mandating the vaccine.

Cholesterol lowering without dangerous drugs

Eat your oranges, and some rice too-

A combination of citrus fruit bioflavonoids and tocotrienols found in the dietary supplement Sytrinol® has shown a positive effect in lowering cholesterol levels, according to a recent study.

Writing in the Alternative Therapies in Health and Medicine journal, researchers stated that the combination of bioflavonoids and tocotrienols, in a three-month diet, cut total cholesterol by 30%. The researchers said physicians and health care practitioners should: “consider this combination of fruit extracts to be a safe and efficacious option for promoting cardiovascular wellness.”

Cardiovascular disease is the number one cause of death in America. According to the American Heart Association, approximately 20% of Americans have high blood cholesterol. Lowering blood cholesterol is one way to help reduce the risk of cardiovascular disease.

For the study, men and women between 19 and 65 years of age were recruited at the Universities of Guelph and Western Ontario. Study subjects had to have total cholesterol levels above 230 mg/dL and LDL >155 mg/dL. They were asked to take a combination of polymethoxyflavones (PMF) from citrus (270 mg/day) and tocotrienols (30 mg/day) or a placebo.

The 12-week double-blind, placebo-controlled study showed total cholesterol dropped by 30%, LDL cholesterol by 29% and triglycerides by 34%, compared to placebo. In addition, HDL levels increased by four percent, resulting in a 29% improvement in the LDL:HDL ratio.

The researchers said the results show the combination of citrus PMFs, plus palm tocotrienols is a “promising natural option” for controlling cholesterol and related cardiovascular risk factors in patients with elevated cholesterol levels.

Alternative Therapies in Health and Medicine 13(6):44-48, 2007